Active pharmaceutical ingredient (API) manufacturers operating in Canada must establish clearly defined and controlled manufacturing processes to ensure consistency under Health Canada’s newly finalized good manufacturing practices (GMP) guidelines.
The guidelines reflect Canadian reforms enacted late last year that brought parity to GMPs for APIs and finished drugs. Under new mandates that went into effect in November, drugmakers will be required to use only GMP-compliant APIs in finished drugs. The regulations also extend establishment licensing and labeling requirements to all API manufacturers, packagers, labelers, testers and importers.
The finalized guidelines lay out the basic requirements for API GMPs. They include:
- Instructions and procedures written in clear and unambiguous language;
- An established system for recalling APIs from sale;
- Validation of analytical methods and critical processes;
- Release of APIs for sale or further fabrication must be signed off on by a quality control employee;
- Proper controls for samples of raw materials, packaging materials and APIs;
- Recording of all quality-related activities when they are performed; and
- Controls governing storage, handling and transportation of APIs to minimize risk to their quality.
The guidelines also outline the important components of an API manufacturing facility. It should be designed to minimize potential contamination and set aside defined areas for sampling, production, packaging and other operations.
The records that should be maintained at the site include:
- Master production documents, except for importers of APIs;
- Evidence that each lot has been stored and tested and is in accordance with procedures described in the master production documents; and
- Evidence that the finished product testing was carried out, along with the testing results.
Such records should be maintained for one year after the expiration date of the lot or batch. If the lot or batch was retested, such records should be maintained for three years after it has been completely distributed, the guidance reads.
The document also offers insights into stability testing, sampling and complaint handling. It also features a table detailing which parts of the International Conference on Harmonisation’s (ICH) GMPs for APIs, outlined in ICH Q7, are applicable to Health Canada’s regulations.
The new guidelines swiftly follow another guideline that updates the quality information drugmakers must submit in new drug applications.
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